RESEARCH TRIANGLE PARK, NC, USA I September 21, 2017 I BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) a biotechnology company focused on the development and commercialization of treatments for rare and infectious diseases, announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application for RAPIVAB (peramivir injection), an intravenous (i.v.) neuraminidase inhibitor, extending its availability for the treatment of acute uncomplicated influenza to pediatric patients 2 years and older who have been symptomatic for no more than two days. The pediatric approval was based on the interim analysis of an ongoing pediatric clinical study. Those results will be presented at the upcoming ID Week 2017 meeting in San Diego.
“This approval represents the first new influenza antiviral for pediatric use in over 10 years,” said Jon P. Stonehouse, President & Chief Executive Officer. “RAPIVAB provides another treatment option for pediatric patients with acute, uncomplicated influenza and represents another important milestone for BioCryst.”
“RAPIVAB is a great addition to our armamentarium of antiviral agents to combat influenza,” said John A. Vanchiere, MD, PhD, Chief, Section of Pediatric Infectious Diseases at LSU Health Sciences Center. “It will be especially helpful for patients who cannot tolerate oral medications. In addition, the long half-life allows for one-time dosing which will improve compliance.”
About RAPIVAB (peramivir injection)
Approved by FDA in December 2014, RAPIVAB (peramivir injection) is an intravenous viral neuraminidase inhibitor approved for the treatment of acute uncomplicated influenza in patients 2 years and older who have been symptomatic for no more than two days. Efficacy of RAPIVAB is based on clinical trials of naturally occurring influenza in which the predominant influenza infections were influenza A virus and a limited number of patients infected with influenza B virus. Visit http://www.rapivab.com to learn more.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals designs, optimizes and develops novel small molecule drugs that block key enzymes involved in rare diseases. BioCryst has several ongoing development programs: BCX7353 and other second generation oral inhibitors of plasma kallikrein for hereditary angioedema, and galidesivir, a broad spectrum viral RNA polymerase inhibitor that is a potential treatment for filoviruses. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst’s first approved product and has received regulatory approval in the U.S., Canada, Japan, Taiwan and Korea. Post-marketing commitment development activities for RAPIVAB are ongoing, as well as activities to support regulatory approvals in other territories. For more information, please visit the Company’s website at www.BioCryst.com.
SOURCE: BioCryst Pharmaceuticals
Post Views: 35
RESEARCH TRIANGLE PARK, NC, USA I September 21, 2017 I BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) a biotechnology company focused on the development and commercialization of treatments for rare and infectious diseases, announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application for RAPIVAB (peramivir injection), an intravenous (i.v.) neuraminidase inhibitor, extending its availability for the treatment of acute uncomplicated influenza to pediatric patients 2 years and older who have been symptomatic for no more than two days. The pediatric approval was based on the interim analysis of an ongoing pediatric clinical study. Those results will be presented at the upcoming ID Week 2017 meeting in San Diego.
“This approval represents the first new influenza antiviral for pediatric use in over 10 years,” said Jon P. Stonehouse, President & Chief Executive Officer. “RAPIVAB provides another treatment option for pediatric patients with acute, uncomplicated influenza and represents another important milestone for BioCryst.”
“RAPIVAB is a great addition to our armamentarium of antiviral agents to combat influenza,” said John A. Vanchiere, MD, PhD, Chief, Section of Pediatric Infectious Diseases at LSU Health Sciences Center. “It will be especially helpful for patients who cannot tolerate oral medications. In addition, the long half-life allows for one-time dosing which will improve compliance.”
About RAPIVAB (peramivir injection)
Approved by FDA in December 2014, RAPIVAB (peramivir injection) is an intravenous viral neuraminidase inhibitor approved for the treatment of acute uncomplicated influenza in patients 2 years and older who have been symptomatic for no more than two days. Efficacy of RAPIVAB is based on clinical trials of naturally occurring influenza in which the predominant influenza infections were influenza A virus and a limited number of patients infected with influenza B virus. Visit http://www.rapivab.com to learn more.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals designs, optimizes and develops novel small molecule drugs that block key enzymes involved in rare diseases. BioCryst has several ongoing development programs: BCX7353 and other second generation oral inhibitors of plasma kallikrein for hereditary angioedema, and galidesivir, a broad spectrum viral RNA polymerase inhibitor that is a potential treatment for filoviruses. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst’s first approved product and has received regulatory approval in the U.S., Canada, Japan, Taiwan and Korea. Post-marketing commitment development activities for RAPIVAB are ongoing, as well as activities to support regulatory approvals in other territories. For more information, please visit the Company’s website at www.BioCryst.com.
SOURCE: BioCryst Pharmaceuticals
Post Views: 35
